FDA Recall D-0036-2026

Aspiro Pharma Limited

Class II Ongoing 225 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).

Lot / code: Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.

Reason for recall

Presence of Particulate Matter: Particulate matter identified as glass

Recall record

Recall number: D-0036-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2025-10-01
Classified by FDA Center: 2025-10-21
FDA published: 2025-10-29
Recalling firm: Aspiro Pharma Limited

Drug identification

Brand name(s): KETOROLAC TROMETHAMINE
Generic name(s): KETOROLAC TROMETHAMINE
Manufacturer(s): Camber Pharmaceuticals, Inc.
NDC(s): 31722-305, 31722-306, 31722-307
Route(s): INTRAMUSCULAR, INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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