Amphastar Recalls Ketorolac Injection Due to Crystallization
Amphastar Pharmaceuticals is recalling Ketorolac Tromethamine Injection because crystallization was observed in retained samples.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Amphastar Pharmaceuticals, Inc. is recalling Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials. The recall involves 637,810 vials distributed throughout the United States.
The recall was initiated because crystallization, specifically particulate matter identified as Ketorolac Calcium Salt, was observed from several lots of retained samples. The affected lots include specific expiration dates ranging from December 2017 to March 2019.
Healthcare providers and patients should discontinue use of the affected vials and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
- Manufacturer
- Amphastar Pharmaceuticals, Inc.
- Category
- Drug — Injection
- Affected units
- 637,810
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot # XI002A6
- XI003A6
- Exp 12/17
- XI004G6
- XI005G6
- Exp 6/18
- XI007H6
- Exp 7/18
- XI00816
- XI00916
- XI01016
- XI01116
- Exp 8/18
- XI012J6
- XI013J6
- Exp 9/18
- XI015K6
- Exp 10/18
- XI016L6
- Exp 11/18
Distribution
Distribution scope not specified by the agency.
Related recalls
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateHospira Recalls Ketorolac Tromethamine Injections Due to Crystallization
FDA (Drugs) · 2015-07-22
- ModerateRemedyRepack Recalls Ketorolac Tromethamine Injection Due to Crystallization
FDA (Drugs) · 2015-05-13
- HighHospira Recalls Ketorolac Tromethamine Injection Due to Crystallization
FDA (Drugs) · 2015-04-15
- HighKetorolac injection vials recalled after glass particulate found in product
FDA (Drugs) · 2025-10-29
- ModerateRemedyRepack Recalls Ketorolac Tromethamine Injection Vials Due to Crystallization
FDA (Drugs) · 2015-04-15
- SevereHikma Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
FDA (Drugs) · 2020-01-22